TW202136747A - Methods and devices for performing an analytical measurement - Google Patents

Abstract

A method of performing an analytical measurement based on a color formation reaction in an optical test strip (114) by using a mobile device (112) having a camera (118), at least one display (120) and a position sensor (124), is disclosed. The method comprises: a) providing a dry optical test strip (114) having a test field (128); b) capturing at least one first image of at least part of the test field (128) of the dry optical test strip (114) without having a sample (130) applied thereto by using the camera (118); c) applying a sample (130) of bodily fluid to the test field (128) of the optical test strip (114); d) capturing at least one second image of at least part of the test field (128) of the optical test strip (114) having the sample (130) applied thereto by using the camera (118); e) determining at least one item of admissibility information, wherein the item of admissibility information indicates admissibility in case the position of the mobile device (112) is substantially the same for capturing the first and the second image, wherein the item of admissibility information is determined based on one or both of position sensor data and local position data; and f) if the item of admissibility information indicates admissibility, determining an analytical measurement result value by using the first and the second image of the test field (128) of the optical test strip (114). Further, a computer program, a computer-readable storage medium, a mobile device (112) and a kit (110) for performing an analytical measurement are disclosed.

Description

Method and device for performing analysis and measurement

The invention relates to a method for performing analysis and measurement based on the color formation reaction in an optical test strip by using a mobile device with a camera. The present invention also relates to a computer program and a computer-readable storage medium with a program tool for executing the method of the present invention. In addition, the present invention relates to a mobile device and kit for performing analytical measurements. The method, computer program, mobile device and kit of the present invention can be used in medical diagnosis, for example, for the qualitative detection of one or more analytes in one or more body fluids. However, the present invention can also be applied to other fields.

In the field of medical diagnostics, in many cases, one or more analytes must be detected in a body fluid (such as blood, interstitial fluid, urine, saliva, or other types of body fluids). The analytes to be detected are, for example, glucose, triglycerides, lactic acid, cholesterol, or other types of analytes commonly present in these body fluids. Depending on the concentration and/or presence of the analyte, if necessary, an appropriate treatment can be selected. Without limiting the scope, the present invention can be specifically illustrated with regard to blood glucose measurement. However, it should be noted that the present invention can be used for other types of analytical measurements using test elements.

Generally speaking, devices and methods known to those skilled in the art utilize test elements containing one or more test chemicals, wherein the one or more test chemicals can perform one or more detectable tests when the analyte to be detected is present. The detection response, such as an optically detectable detection response. For example, EP 0 821 234 A2 describes a diagnostic test carrier for determining an analyte from whole blood with the aid of a reagent system contained in the carrier, and a method for determining an analyte from whole blood with the aid of a diagnostic test carrier. The diagnostic test carrier contains a coupler. The test field has a specimen application end and a detection end. The blood sample is transported to the specimen application end, and an optically detectable change occurs at the detection end due to the reaction between the analyte and the reagent system. Furthermore, the test field is designed so that the red blood cells contained in the specimen will not reach the detection end. In addition, the test field includes a transparent film and a first laminated film layer and a second laminated film layer applied thereon, wherein the light scattering of the first layer laminated on the transparent film in the wet state is substantially less than that of the overlapped film. Second floor.

Regarding the test chemicals contained in the test element, refer to, for example, J. Hoenes et al.: The Technology Behind Glucose Meters: Test Strips, Diabetes Technology & Therapeutics, Volume 10, Supplement 1, 2008, S-10 to S-26 . Other types of test chemicals are feasible and can be used to implement the present invention.

In analytical measurement, specifically based on the color formation reaction, a technical challenge is to evaluate the color change caused by the detection reaction. In addition to using dedicated analysis devices such as hand-held blood glucose meters, the use of general-purpose electronic devices such as smart phones and portable computers has also become more and more popular in recent years. In contrast to measurements performed by using dedicated analytical measurement devices, various effects need to be considered when using mobile computing devices such as smartphones. For example, lighting conditions, positioning, vibration, or other conditions that are more or less uncontrollable will be considered. In the technical field of mobile computing devices, various technical methods have been developed in recent years to improve image recognition and/or obtain additional information about, for example, unknown geometric parameters of the device.

Therefore, for example, US 2014/0170757 A1 describes a method for a portable computing device to read the reaction area on a test strip, the test strip is located in a peripheral device, the peripheral device is placed in the portable computing device Above the image sensor and light source. A light source is used to provide light, with the peripheral device facing the reaction area. Use the image sensor to capture the image containing the reaction area. The analyte characteristics are determined based on the color of the reaction area in the captured image.

In addition, WO 2018/115346 A1 describes a system for capturing the measurement image of the object to be measured, including a mobile electronic device, where the mobile electronic device includes: a housing; The measurement image of the object to be measured is recorded inside; the screen combined with the housing is used to display the image in a luminous manner, wherein the screen faces the observation area of the camera; combined with the control unit of the housing, the control unit is configured to start the action The screen of the electronic device displays a plurality of different illumination images of a predetermined illumination image sequence, wherein the control unit is configured to activate the camera of the mobile electronic device to display the predetermined illumination image sequence in each case. The two illumination images simultaneously capture a measurement image of the object to be measured. In addition, the present invention relates to corresponding methods and computer program products.

US 9,886,750 B2 describes an electronic device that is used to read diagnostic test results and collect subject data, to be included in the local chain of the evidence database, and to transmit and receive data from a remote database.

In addition, US 9,322,767 B2 describes a device and method for performing point-of-care blood, cell and/or pathogen counts or similar blood tests. What is disclosed is a system that can be used to provide rapid, accurate, and affordable laboratory quality testing in designated care. The described system is capable of imaging and counting individual cells in prepared cell specimens (for example, peripheral blood smears or blood specimens prepared in a microfluidic device) or in another prepared cell-containing specimen, Without the need for microscopes or other expensive and troublesome optics. The described system aims to eliminate or replace expensive centralized clinical testing equipment and technicians. Such a system can include automatic data reporting and decision support.

US 2014/0005498 A1 describes a method that includes using a camera of a mobile electronic device to capture a photo of at least one eye of a patient, a photo of a patient's finger, and a photo of at least one medication taken by the patient. The method may also include performing an exercise test on the patient, and storing the result of the exercise test together with the captured photos in a database.

In addition, you can download software applications for smartphones, such as the ACCU-CHEK®SugarView application from Roche Diabetes Care GmbH, Germany, available from https://www.accu-chek-sugarview.com.

US 2018/024049 A1 describes a method and calorimetry device for performing colorimetric analysis of test fluids to evaluate relevant physiological parameters. The images of the test strips of different heights are captured by the calorimeter, and a plurality of geometric parameters respectively associated with the test strips are determined based on the analysis of the captured images. Based on a plurality of geometric parameters, the coefficient of image re-sizing is determined, and the resized image is generated based on the coefficient of image re-sizing. When generating the resized image, based on the evaluation of the physiological parameters associated with the test fluid, the caloric values respectively related to the resized image are determined.

WO 2012/131386 A1 describes a test device for performing a test. The test device includes: a container containing a reagent that reacts with an applied test specimen by developing color or pattern changes; portable A device (such as a mobile phone or a laptop computer), which includes a processor and an image capture device, wherein the processor is configured to process the data captured by the image capture device and output a test for the applied test Physical test results.

EP 1 801 568 A1 describes a method that involves positioning the camera at the test strip for graphical detection of color indicators and reference color areas. Determine the measured value of the relative position between the camera and the test strip and compare it with the expected value area. Move the camera to reduce the deviation relative to the test strip during the deviation between the measured value and the expected value. The image area assigned to the pointer is positioned in the color image detected by the camera. The analyte concentration in the sample is determined by comparing the value.

Despite the advantages of using mobile computing devices to perform analytical measurements, there are still some technical challenges. Specifically, it is necessary to strengthen and ensure the reliability and accuracy of the measurement. The main challenge is the existence and influence of different environmental conditions (such as lighting conditions). Therefore, the measurement result may largely depend on the environment to be set up and/or the background lighting. Therefore, even under the same chemical or biochemical conditions, the measurement result may vary from measurement to measurement. In addition, the measurement result may depend on the relative positioning of the camera of the lighting device and the mobile device. Since there are a large number of different mobile devices on the market, it can vary for different types or models of mobile devices. These technical challenges are even magnified by the fact that, generally speaking, when performing analytical measurements by using optical test strips, at least two images need to be taken and analyzed, one of which shows at least part of the test without specimens applied Field, and at least one second image is obtained with the specimen applied thereon, wherein the application of the second image is usually performed after waiting for a certain period of time until a color forming reaction occurs. In this case, it is necessary to compare at least two images, and the test strip is usually processed and repositioned between the two images. Therefore, the uncertainty of the measurement is additionally increased. The problem you want to solve

Therefore, it is desirable to provide methods, computer programs, and devices that can solve the above-mentioned technical challenges of using mobile devices for analysis and measurement, such as the use of consumer electronic mobile devices, specifically multifunctional mobile devices that are not dedicated to analysis and measurement, such as smart phones or tablet. Specifically, methods, computer programs, and devices to ensure the reliability and accuracy of the measurement should be proposed.

This problem is solved by using methods, computer programs, computer-readable storage media, mobile devices, and sets that have the characteristics of independent request items for performing analysis and measurement. Advantageous embodiments that can be implemented individually or in any arbitrary combination are listed in the appended claims.

As used hereinafter, the terms "have", "comprise" or "include" or any of their grammatical changes are used in a non-exclusive manner. Therefore, these terms can refer to a situation in which no further features exist in the entity described in this article other than the features introduced by these terms, or can refer to the presence of one or more further features. The situation. As an example, the expressions "A has B", "A includes B", and "A includes B" can refer to the situation in which no other components exist in A except for B (that is, where A is only and exclusively by B) and can also refer to a situation in which one or more further elements (such as elements C, elements C and D or even further elements) other than B exist in entity A.

In addition, it should be noted that the terms "at least one", "one or more" or similar expressions that indicate that a feature or element may exist once or more than once are usually used to introduce individual features Or components will only be used once. Hereinafter, in most cases, when referring to individual features or elements, the expressions "at least one" or "one or more" will not be repeated, although there are individual features or elements that may exist once or more than once. fact.

Further, as used hereinafter, the terms "preferably", "more preferably", "particularly", "more particularly", "specific "Specifically", "more specifically" or similar terms are used with optional features without limiting the possibilities of alternatives. Therefore, the features introduced by these terms are optional features and are not intended to limit the scope of the patent application in any way. Those skilled in the art will recognize that the present invention can be implemented by using alternative features. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, and there are no restrictions on alternative embodiments of the present invention. The scope of the present invention is not limited in any way and there is no limit to the possibility of combining the features introduced in this way with other optional or non-optional features of the present invention.

In the first aspect, what is disclosed is a method for performing analysis and measurement based on the color formation reaction in an optical test strip by using a mobile device with a camera. The method contains the following steps, as an example, these steps can be performed in the given order. However, it should be noted that a different order is also possible. In addition, one, more than one, or even all of the method steps may be performed at once or repeatedly. It is also possible to perform two or more method steps simultaneously or in a timely overlapping manner. The method may include other method steps not listed.

Generally speaking, the method includes the following steps: a) Provide dry optical test strips with test field; b) by using the camera to capture at least one first image of at least a part of the test field of the dry optical test strip where no specimen is applied; c) Apply the body fluid sample to the test field of the optical test strip; d) by using the camera to capture at least one second image of at least a part of the test field of the optical test strip to which the specimen is applied; e) Determine at least one piece of admissibility information. In the case where the location of the mobile device is substantially the same as the location where the first image and the second image are captured, the indication of the admissibility information is admissible, where , To determine the admissibility information based on one or both of the position sensor data and the local position data; and f) If the admissibility information indication is admissible, the first image and the second image of the test field using the optical test strip are used to determine the analytical measurement result value.

As used herein, the term "analytical measurement" is a broad term, and should be given ordinary and customary meanings to those with ordinary knowledge in the technical field, and is not limited to special or customized meanings . The term may specifically refer to the quantitative and/or qualitative determination of at least one analyte in any sample, but is not limited to it. The specimen contains body fluids, such as blood, interstitial fluid, urine, saliva, or other types of body fluids. For example, the result of the analytical measurement may be the concentration of the analyte and/or the presence or absence of the analyte to be determined. In particular, the analyte can be glucose. Specifically, for example, the analysis measurement may be a blood glucose measurement, so the result of the analysis measurement may be a blood glucose concentration. In particular, the analytical measurement result value can be determined by analytical measurement. As used herein, the term "analytical measurement result value (analytical measurement result value)" is a broad term, and should be given its ordinary and customary meaning to those with ordinary knowledge in the technical field, and is not limited to special or The meaning of customization. The term can specifically refer to any numerical indication of the concentration of the analyte in the sample, but is not limited to it.

For example, the at least one analyte may be or may include one or more specific chemical compounds and/or other parameters. For example, one or more analytes involved in metabolism can be determined, such as blood glucose. Additionally or alternatively, other types of analytes or parameters can be determined, such as pH. Specifically, the at least one specimen may be or may contain at least one body fluid, such as blood, interstitial fluid, urine, saliva, and the like. However, additionally or alternatively, other kinds of specimens, such as water, may be used.

As used herein, the term "sample" is a broad term, and should be given ordinary and customary meanings to those with ordinary knowledge in the technical field, and is not limited to special or customized meanings. The term can specifically refer to any amount of liquid used for analysis and measurement, but is not limited to it. In particular, the specimen may be a body fluid specimen, and may be or may contain at least 2 microliters (μl) of body fluids, in one embodiment, at least 5 microliters (μl) of body fluids, such as blood, interstitial fluid One or more of, urine, saliva and other body fluids. Specifically, the body fluid sample may contain at least a minimum amount of body fluid required for performing analysis and measurement, specifically the minimum amount of body fluid used to representatively determine the concentration of the analyte in the body fluid.

The analytical measurement may specifically be an analytical measurement, including a change in at least one optical characteristic of the optical test strip, and the change can be visually measured or determined by using a camera. Specifically, the analytical measurement may be or may include a color forming reaction in the presence of at least one analyte to be determined. As used herein, the term "color formation reaction" is a broad term, and should be given its ordinary and customary meaning to those with ordinary knowledge in the technical field, and is not limited to a special or customized meaning. The term may specifically refer to a chemical, biological or physical reaction during which the color of at least one element involved in the reaction (specifically reflectance) changes as the reaction progresses, but is not limited to it.

As used herein, the term "optical test strip (color formation reaction)" is a broad term and should be given its ordinary and customary meaning to those with ordinary knowledge in the technical field, and is not limited to special or customized Meaning. The term may specifically refer to any element or device comprising at least one strip-shaped carrier, which has at least one test field applied thereto or integrated therein, and the element is configured to perform a color change detection reaction, but is not limited to it . The optical test strip may also involve a test strip or a test element. The optical test strip may in particular have a test field containing at least one test chemical for detecting at least one analyte, such as at least one reagent element. For example, the optical test strip may include at least one substrate having at least one test field applied thereto or integrated therein, such as at least one carrier. In particular, the optical test strip may further include at least one white area, such as a white field, specifically in a place close to the test field, such as surrounding or surrounding the test field. The white area can be a separate field independently arranged on the substrate or carrier. However, additionally or alternatively, the substrate or carrier itself may be or may contain white areas. Such test strips are generally widely used and available. A test strip can have a single test field or multiple test fields, which contain the same or different test chemicals.

In step c), the body fluid sample is applied to the test field of the optical test strip; for example, at least one drop of the sample (for example, at least 2 to 5 µl of body fluid) can be applied to the test field. For example, the specimen can be dropped and/or painted on the test field. Various application techniques are possible, such as applying the specimen to the test field from the back of the test field, and capturing the first image and the second image from the front.

As used further herein, the term "test field" is a broad term and should be given its ordinary and customary meaning to those with ordinary knowledge in the technical field, and is not limited to special or customized meaning. The term may specifically refer to the coherent quantity of the test chemical, such as a field with one or more layers of material (for example, a circular, polygonal, or rectangular field), and at least one layer of the test field has the test chemical contained therein, but not as limit.

As used herein, the term "mobile device" is a broad term and should be given its ordinary and customary meanings to those with ordinary knowledge in the technical field, and should not be limited to special or customized meanings. The term may specifically refer to mobile electronic devices, and more specifically to mobile communication devices, such as mobile phones or smart phones, but is not limited to them. Additionally or alternatively, as will be described in further detail below, the mobile device may also involve a tablet computer with at least one camera or another type of portable computer.

As used herein, the term "camera" is a broad term and should be given its ordinary and customary meanings to those with ordinary knowledge in the technical field, and should not be limited to special or customized meanings. The term may specifically refer to a device having at least one imaging element configured to record or capture spatially resolved one-dimensional, two-dimensional, or even three-dimensional optical data or information, but is not limited thereto. For example, the camera may include at least one camera chip, such as at least one CCD chip and/or at least one CMOS chip configured to record images. As used herein, the term "image" may specifically refer to data recorded by using a camera, such as a plurality of electronic readings from an imaging device, such as pixels of a camera chip, but is not limited thereto.

In addition to at least one camera chip or imaging chip, the camera may also include additional elements, such as one or more optical elements, for example, one or more lenses. For example, the camera may be a fixed focal length camera, which has at least one lens that is fixedly adjusted relative to the camera. However, alternatively, the camera may also include one or more variable lenses that can be adjusted automatically or manually. The present invention should be specifically applicable to cameras generally used in mobile applications, such as notebook computers and tablet computers, or specifically mobile phones, such as smart phones. Therefore, in particular, the camera may be part of a mobile device, which in addition to the at least one camera also includes one or more data processing devices, such as one or more data processors. However, other cameras are also feasible.

The camera may specifically be a color camera. Therefore, for example, for each pixel, color information can be provided or generated, such as the color values of the three colors R, G, and B. A larger number of color values are also feasible, such as four color values for each pixel, for example R, G, G, B. Color cameras are generally known to the skilled person. Therefore, for example, a camera chip can be composed of three or more different color sensor complexes, such as color recording pixels, where one pixel is used for red (R), one pixel is used for green (G), and one pixel is used for In blue (B). For each pixel, such as for R, G, and B, a value is recorded by the pixel according to the intensity of the respective color, such as a digital value in the range of 0 to 255. Instead of using color triples such as R, G, and B, for example, quadruples such as R, G, G, and B can be used. The color sensitivity of the pixel can be generated by the color filter or by the appropriate inherent sensitivity of the sensor element used in the camera pixel, and these techniques are generally known to the skilled person.

Step b) and step d) each include capturing at least one image by using a camera. The term "capturing at least one image" may refer to one or more of imaging, image recording, image capturing, and image capturing. The term "capturing at least one image" may include capturing a single image and/or multiple images, such as a series of images. For example, the capturing of images may include the continuous recording of a series of images, such as movies or movies. The capture of at least one image can be activated by a user action or can be automatically activated, for example, once it is automatically detected that at least one object exists in the camera's field of view and/or a predetermined sector of the field of view. These automatic image capture technologies are known, for example, in the field of automatic barcode readers, such as from automatic barcode reading applications. For example, image capture can be performed by using a camera to capture an image stream or image "live stream", in which one or more images are automatically or through user interaction (such as pressing a button) Respectively stored as and used as at least one first image or at least one second image. Image capture can be supported by the processor of the mobile device, and the image storage can be performed in the data storage device of the mobile device.

In each step b) and step d), at least one image of at least a part of the test field is captured by using a camera. These images are called "the at least one first image" and "the at least one second image", where the terms "first" and "second" are only For naming purposes, no ranking or numbering of these images is made, and no preference is given. The term "of at least a part of the test field" or "of at least part of the test field" refers to the fact that in each image, at least At least a part of a test field, wherein, in the first image and the second image, different parts of the at least one test field can be seen. In addition to at least a part of the test field, in each case other parts of the optical test strip can be seen, such as at least a part of the substrate of the test strip.

In step b), at least one first image is captured without applying the specimen to the test field. This at least one first image is usually also called a "blank image", and, in a typical evaluation method, the image is only used for reference purposes to take into account changes in the color or other optical characteristics of the test field. These changes are not Caused by the sample or the analyte itself. For example, in step c), the sample application can be performed directly or indirectly, for example via at least one capillary element. Even though the specimen may be dry when the image is actually captured, at least one second image captured after the specimen is applied is usually called a "wet image." Usually after waiting for at least a predetermined waiting time, such as five seconds or more, a second image is taken to allow the detection reaction to proceed.

Therefore, for example, between steps c) and d) of the method, there may be a minimum waiting time. The minimum waiting time may specifically be sufficient for the detection reaction in the test strip. For example, the minimum waiting time can be at least 5 seconds.

In step e), at least one piece of admissibility information is determined, wherein if the location of the mobile device used to capture the first image is substantially the same as the location of the mobile device that captures the second image, the piece of admissibility information is only The instructions are admissible. The term "position" as used herein and specifically as used in the context of capturing the first image and the second image by a mobile device is a broad term and should be given to those with ordinary knowledge in the technical field Its ordinary and customary meanings are not limited to special or customized meanings. The term may specifically refer to at least one piece of spatial information related to a camera (such as a camera of a mobile device), but is not limited to it. The position of the mobile device can particularly relate to an absolute position in space. The position may be the position of the camera when the image was captured. The position may particularly relate to at least one of the spatial coordinates and/or spatial orientation of the camera and/or the mobile device. Especially when the location (such as spatial information) of the mobile device (such as the camera of the mobile device) is substantially the same as the location where the first image and the second image are captured, the admissibility information indication is admissible.

As used herein, the term "admissibility" is a broad term, and should be given ordinary and customary meanings to those with ordinary knowledge in the technical field, and is not limited to special or customized meanings. The term may specifically refer to the characterization of whether the element or device is allowed and/or refused to perform one or more predetermined functions, but is not limited thereto. Therefore, for example, by using one or more location parameters of the device, qualitative or quantitative admissibility can be achieved. These one or more positional parameters can be compared with one or more conditions. As a simple example, one or more positional parameters can be compared with one or more comparison values, reference values, or standard values, where the comparison can lead to a binary result, such as "admissible" or " Not admissible"/"inadmissible". For example, the at least one comparison value and/or reference value may include at least one threshold, such as the maximum difference between the positions of the camera and/or the mobile device when capturing the first image and the second image. For example, the comparison value, reference value, and/or standard value can be derived from experiments or from boundary conditions (for example, to be determined by analyzing the accuracy to be achieved in the measurement).

As used herein, the term "item of admissibility information" is a broad term, and should be given ordinary and customary meanings to those with ordinary knowledge in the technical field, and is not limited to special Or the meaning of customization. The term may specifically refer to an information indication about admissibility, but is not limited to it. In particular, the admissibility information may relate to an indication for determining the admissibility of the analytical measurement result value from the first image and the second image captured by the camera of the mobile device, and/or it may relate to the indication for capturing the second image. An indication of the admissibility of the camera of the image mobile device. For example, the admissibility information can be Boolean or digital information, such as indicating "admissible" or "not admissible"/"inadmissible" . Therefore, for example, when the position of the mobile device (such as the camera of the mobile device) when the second image is captured is relative to the position of the mobile device when the first image is captured, the Analyzing the measurement result value, the capture of the second image and/or the second image itself (specifically when the image has been captured) can be determined as unacceptable.

In the case where the location of the mobile device is substantially the same as the location where the first image and the second image are captured, the admissibility information is specifically indicated as admissible. As used herein, the term "substantially the same", specifically as used in the context of the location of the mobile device, is a broad term and should be given to those with ordinary knowledge in the technical field. And customary meanings, not limited to special or customized meanings. The term may specifically refer to the following fact, but is not limited to it: the first image and the second image are taken at a location that meets at least one predetermined or determinable similarity criterion. Therefore, for example, when capturing the first image and the second image, the position of the mobile device may be the same at least within a predetermined allowable range, such as the predetermined allowable range stored in at least one data storage device of the mobile device.

Specifically, the predetermined allowable range can be measured by at least one sensor of the mobile device (for example, by at least one acceleration sensor). In particular, the predetermined tolerance range can be measured by at least one acceleration sensor of the mobile device, wherein the acceleration sensor can be configured to measure the acceleration of the mobile device in any coordinate system, for example, in a Cartesian coordinate system One or more of, cylindrical coordinate system, polar coordinate system and spherical coordinate system. For example, the predetermined allowable range may specifically or may include a position difference, such as a position difference r in a three-dimensional polar coordinate system and/or a spherical coordinate system, 0 m ≤ r ≤ 0.05 m, specifically 0 m ≤ r ≤ 0.03 m, more specifically 0 m ≤ r ≤ 0.01 m.

As further noted above, in step e), at least one piece of admissibility information is determined based on one or both of the position sensor data and the local position data.

For example, the position sensor data may be data retrieved from the position sensor of the mobile device. As used herein, the term "position sensor" is a broad term, and should be given ordinary and customary meanings to those with ordinary knowledge in the technical field, and is not limited to special or customized Meaning. The term can specifically refer to any component, which is suitable for determining the spatial information of the camera of the mobile device, for example, for detecting position and/or position change, but is not limited to it. The position sensor may be at least one position sensor of the mobile device, so at least part of it may be located in the mobile device. In particular, the position sensor of the mobile device can be specifically configured to detect the position and/or the change of the position of the mobile device. Specifically, the position sensor can be configured to generate position sensor data.

As used herein, the term "position sensor data" is a broad term and should be given ordinary and customary meanings to those with ordinary knowledge in the technical field, and is not limited to special or The meaning of customization. The term can specifically refer to any form of information, such as a signal generated by a position sensor, which indicates, but is not limited to, a position and/or a change in position. For example, the position sensor data generated by the position sensor may be or may include at least one electronic signal, such as at least one voltage and/or at least one current, according to changes in position and/or position. Therefore, the position sensor data may be or may include at least one signal generated by the position sensor of the mobile device, which indicates the position of the mobile device quantitatively and/or qualitatively. For example, the position sensor may be or may include one or more of a gyroscope, a motion sensor, an accelerometer, a Hall sensor, and a barometer.

As used herein, the term "local position data" is a broad term, and should be given ordinary and customary meanings to those with ordinary knowledge in the technical field, and is not limited to special or customized Meaning. The term may specifically refer to spatial information related to one or more of the camera or test field, such as at least one item of spatial information, where at least one item of spatial information takes into account at least one environmental feature, but is not limited to it. Specifically, the local location data may be or may include spatial information related to the location of at least one environmental feature in the camera's field of view. The local location data may refer to the location of one or more of the camera or the test field at the time and/or during the capturing of the image (such as at the moment of capturing the image). For example, the local location data may be or may include spatial information. The spatial information refers to at least one spatial coordinate and/or spatial orientation, such as at least one spatial coordinate and/or at least one spatial orientation. In at least one coordinate system defined. For example, the local location information can be derived from images captured using a camera, such as from one or both of the first image and the second image. The local location data, which is the opposite of the location sensor data, can depend on external elements (such as based on environmental characteristics) and can be derived independently of the location sensor. For example, the local location data can be determined by image analysis including, for example, target recognition software.

As used herein, the term "environmental feature" is a broad term and should be given ordinary and customary meanings to those with ordinary knowledge in the technical field, and not limited to special or customized meanings . The term can specifically refer to any reference element and/or reference feature in the camera's field of view, but is not limited to it. The environmental feature is specifically suitable for defining a position and/or coordinate system in space, and/or it can be used as a position marker in the camera's field of view. The environmental feature may specifically be a feature that has a fixed and/or unchanging position between capturing the first image and the second image. The fixed and/or unchanging position of the environmental feature may particularly involve a fixed and/or unchanging absolute position in space. The environmental feature may specifically be a feature that may not change the position between capturing the first image and the second image. The environmental feature may be or may include an item or a part thereof, such as a table or a part of a table, such as the surface structure of the table. The at least one environmental feature may specifically include at least one of the item in the camera field of view or the structural feature of the item in the camera field of view. Environmental features or items can be physical. The environmental characteristics may be different from the test strip or part of the test strip, and also different from the mobile device with a camera or a part thereof.

In order to detect at least one environmental feature, the method may include detecting at least one environmental feature in one or both of the first image and the second image. To this end, for example, the method can use image recognition, such as software-based automatic image recognition and/or image recognition through a machine learning process.

The method may further include: g) If the admissibility information instruction is not admissible, perform one or both of the following: -Display an error message on the display screen of the mobile device; and -Stop the method of performing analysis and measurement.

The mobile device specifically has at least one display screen. As used herein, the term "display", specifically as used in the context of mobile devices, is a broad term, and should be given to those with ordinary knowledge in the technical field in common and customary terms. Meaning, not limited to special or customized meanings. The term can specifically refer to, but is not limited to, an illustrative user interface configured to represent information in a visual form. In particular, the term display screen may refer to the screen of a smart phone, a portable tablet computer, or a laptop computer. Specifically, the display screen of the mobile device may have a flat and/or smooth surface. For example, the display screen may be a liquid crystal display (LCD) such as a flat-panel display screen, such as an electronically modulated optical device, which utilizes the light modulation characteristics of liquid crystals. Other types of display screens are also possible, such as light-emitting diode (LED) display screens.

For example, in step g), if the admissibility information indication is unacceptable, an error message can be displayed on the display screen of the mobile device. Therefore, in the case where the admissibility information indication is unacceptable, the display screen can display a note to the user and notify the user of the error (for example, unacceptable). Additionally or alternatively, in step g), if the admissibility information indicates that it is not admissible, the method of performing the analysis and measurement can be suspended. Therefore, in the event that the admissibility information instruction is unacceptable, the method can be terminated.

Step e) of the method may also include retrieving at least one first item of location information and at least one second item of location information of the mobile device. Specifically, step e) may include retrieving at least one first item of location information, which includes information about the location of the mobile device when the first image is captured in step b) of the method. In addition, step e) may include retrieving at least one second item of location information, which includes information about the location of the mobile device when the second image is captured in step d).

In particular, when capturing the first image in step b), the first item of location information may be or may include at least one location sensor data of the mobile device. Therefore, for example, the first location information can be retrieved from the location sensor of the mobile device.

When capturing the second image in step d), the second item of location information may specifically be or may include at least one location sensor data of the mobile device. Therefore, for example, the second location information can be retrieved from the location sensor of the mobile device.

For example, the first item of location information may be or may include at least one local location data, for example, when the first image is captured in step b), the local location data of the mobile device relative to the test field. Therefore, for example, the first location information can be retrieved from the first image captured by the mobile device.

In particular, when capturing the second image in step d), the second item of location information may specifically be or may include at least one local location data of the mobile device. Therefore, for example, the second location information can be retrieved from the second image captured by the mobile device.

In particular, step e) may further include comparing the second item of location information with the first item of location information. Specifically, in step e), for example, in order to determine at least one piece of admissibility information, the first piece of location information and the second piece of location information may be compared with each other.

For example, in a case where the second item of location information is at least the same as the first item of location information within a predetermined allowable range, the admissibility information may be indicated as admissible. In general, if the second item of location information is substantially the same as the first item of location information, the admissibility information can be indicated as admissible. Otherwise, such as when the second item of location information is different from the first item of location information, for example, it is not within a predetermined allowable range, the admissibility information may be indicated as unacceptable.

The local position data may specifically include information about at least one of the following: the relative position between the camera and at least one environmental feature in the camera's field of view; the relative position between the test field and at least one environmental feature in the camera's field of view; In a coordinate system defined by at least one environmental feature in the camera field of view, the relative position between the camera and the test field; the relative orientation between the camera and at least one environmental feature in the camera field of view; the test field and the camera The relative orientation between at least one environmental feature in the field of view; the relative orientation between the camera and the test field in the coordinate system defined by the at least one environmental feature in the camera field of view. In addition, the local position data may include information about the relative position between the camera and the test field, and/or information about the relative orientation between the camera and the test field.

As used herein, the term "relative position" may specifically refer to a comparative position in space that can be measured only by distance. In particular, as opposed to relative orientation, relative position can be measured independently of rotation considerations. Therefore, for example, the relative position between the camera and any object may refer to the comparison position between the center of gravity of the camera (for example, the center of gravity of a mobile phone including the camera) and the center of gravity of any object. For example, the relative position between the camera and the test field may be related to the comparison position between the camera and the test field, regardless of any rotation.

As used herein, the term "relative orientation" may specifically refer to a comparative alignment in space that can be measured only by rotation. In particular, the relative orientation can be measured independently of distance considerations. Therefore, for example, the relative orientation between the camera and any object may involve the coordinate system located at the center of gravity of the camera (for example, the coordinate system located at the center of gravity of the mobile phone containing the camera) and the coordinate system at the center of gravity of any object. Compare rotation. In particular, for example, the relative orientation between the camera and the test field may involve the comparative rotation difference between the coordinate system of the camera and the coordinate system of the test field, specifically the difference between the coordinate system located at the center of gravity of the camera and the test field Comparison of rotation differences between coordinate systems.

The method may further include the following steps: before performing step b) of capturing the first image, waiting for the mobile device to be stationary. As used herein, specifically as used in the context of mobile devices, the term "at rest" is a broad term and should be given its ordinary and customary meaning to those with ordinary knowledge in the technical field, and It should not be limited to special or customized meanings. The term may specifically refer to, but is not limited to, the temporary state of an unchanging position, such as the position of any object that is temporarily immobile. In particular, the stationary state of the mobile device may refer to the temporary state of the mobile device, wherein the position of the mobile device remains unchanged at least within a predetermined allowable range of movement. For example, if the position of the mobile device is kept within ±5%, specifically within ±3%, for at least 1 second, preferably at least 3 seconds, the mobile device can be considered to be stationary state.

Both the camera and the at least one display screen of the mobile device can be located on the same side of the mobile device. Specifically, the camera may be the front camera of the mobile device. The front camera and the display screen, specifically the front camera and the display screen of the mobile device, can both be located on the front of the mobile device, such as on the front of the mobile device. In particular, the display screen and the front camera can be located on the same side of the mobile device, especially on the front side.

In steps b) and d), specifically when performing steps b) and d) of the method, the mobile device can be positioned at a fixed position by one or both of the following: -Use a stand for the mobile device; and -Place the mobile device on a fixed surface.

As used herein, the term "fixed position" is a broad term, and should be given its ordinary and customary meanings to those with ordinary knowledge in the technical field, and is not limited to special or customized meanings . The term can specifically refer to a constant position in space, but is not limited to it. The position can be given by values in any coordinate system, such as by three-dimensional coordinates and/or angle values. The term "fixed" may refer to a fixed value in the coordinate system. The position can be defined by three-dimensional coordinates and/or orientation in space. In particular, the fixed position may refer to a constant and/or permanent position in space.

In particular, using a stand and/or placing the mobile device on a fixed surface can ensure that the mobile device is in a static state when the first image is captured in step b) and/or the second image is captured in step d). Specifically, for example, using a stand and/or placing the mobile device on a fixed surface can ensure that the position of the mobile device is substantially the same as the position used to capture the first image and the second image.

The fixed surface can be selected from the group consisting of: horizontal surfaces, such as table tops, seating surfaces, floors, and shelves; inclined or sloped surfaces; flat surfaces; irregular surfaces. Specifically, the fixed surface may be or may include any surface suitable for physically supporting the mobile device (for example, resisting gravity, such as resisting gravity).

When at least one first image is captured in step b), the test field of the optical test strip can be illuminated by using the display screen of the mobile device. For example, when the mobile device is used to capture at least one first image, the display screen of the mobile device may be suitable for emitting light, such as illuminating a test field.

When at least one second image is captured in step d), the test field of the optical test strip can be illuminated by using the display screen of the mobile device. For example, when the mobile device is used to capture at least one second image, the display screen of the mobile device may be suitable for emitting light, such as illuminating a test field.

In particular, in order to illuminate the test field, at least one area of the display screen of the mobile device can be illuminated. Therefore, when using a mobile device to capture at least one image, specifically at least one first image and/or second image, at least one area of the display screen can be adapted to emit at least a minimum amount of light to illuminate the test field. In particular, the display screen of at least one area of the mobile device illuminated for illuminating the test field, for example, may or may include at least 10% of the display screen, specifically the total area and/or the entire surface area of the display screen. Preferably, the display screen of at least one area of the mobile device illuminated for illuminating the test field may be or may contain at least 15% of the display screen. More preferably, the display screen of at least one area of the mobile device illuminated for illuminating the test field may be or may contain at least 20% of the display screen.

The method may further include: h) Provide instructions on where to position the optical test strip to capture the first image and/or the second image by using the mobile device.

In particular, the indication of where the optical test strip is located for capturing the first image may be different from the indication of where the optical test strip is located for capturing the second image. Specifically, in step h), an instruction about where to position the optical test strip can be provided, so that the first image and the second image are shot at substantially the same position.

For example, step h) may include indicating where to capture the position of the first image. Step h) may additionally include a position indicating where to capture the second image. Additionally or alternatively, step h) may include indicating the location where the second image was captured based on the location where the first image was captured.

The instruction can be provided specifically by using the display screen of the mobile device. For example, the instruction may specifically include a visual instruction on the display screen of the mobile device. Specifically, the indication of where the optical test strip is located in step h) can be included under visual guidance, superimposing the real-time image of the camera on the display screen of the mobile device.

The visual guide can be specifically selected from the group consisting of: the outline of the target test strip; the pointer indicating the orientation of the test strip; at least one word or phrase indicates the location of the test strip.

In particular, the visual guidance superimposed in the real-time image of the camera may at least partly be or include augmented reality. As used herein, the term "augmented reality" is a broad term, and should be given ordinary and customary meanings to those with ordinary knowledge in the technical field, and is not limited to special or customized Meaning. The term may specifically refer to a method of superimposing the current image, real-time image or image stream of the scene with one or more additional information (such as one or more visual indicators, etc.) on the display screen, but is not limited to it . Therefore, for example, one or more arrows, frames, or lines can be provided on the display screen to indicate the preferred positioning of the camera and/or the test strip to provide an indication of where the optical test strip is positioned. Additionally or alternatively, text may be displayed indicating in which direction the camera and/or test strip may have to be moved. Other visual guidance, such as other augmented reality, are also possible.

Step d) of the method may include capturing a plurality of second images. Specifically, the method may include monitoring the reaction kinetics by using a plurality of second images. For example, multiple second images can be used to monitor reaction kinetics. In an embodiment, the method may be included in the optical characteristics of the test field to determine the change caused by wetting.

For example, the reaction kinetics may include at least one of a change caused by wetting and a change caused by a detection reaction, such as a change of at least one optical property or at least one optical information. In particular, a plurality of second images can be captured in order to determine whether at least one change caused by wetting has occurred. In particular, a plurality of second images can be captured, and can be based on at least one second image captured from one or more captured images within a predetermined period of time (for example, 3 to 8 seconds or 5 to 8 seconds). Determine the analytical measurement value. The one or more captured images indicate the beginning of the change caused by wetting. As a result, the measurement performance can be improved. The detection of changes caused by wetting based on multiple second images can be used as a protective measure to rule out that the reaction time between the sample and the reagent system is too short or too long, because too short or too long a reaction time may lead to erroneous analysis and measurement results. Although the method may further include the step of requesting the user to confirm whether to apply the body fluid sample to the test field, and receiving the confirmation as the start of the reaction, the change caused by wetting is automatically detected based on a plurality of second images. The user is less troublesome.

The method may include using at least one optical test strip, wherein the optical test strip may include at least one reagent element. The reagent element can be specifically configured to perform at least one optically detectable detection reaction in the presence of the analyte.

Furthermore, the method may include a time course of determining at least one optical measurement variable. The time course of the optical measurement variable may include a first period of time, which includes a sudden wetting-induced change in the optical measurement variable (unrelated to the presence of the analyte). In particular, the time course of the optically measured variable may further comprise a second time period, which may be after the first time period. The second period may include the reaction kinetics (reaction of the reagent element detection in the presence of the analyte) for determining the concentration of the analyte.

The test field of the optical test strip can be arranged on the detection side of the optical test strip. The optical test strip may further comprise a specimen application side, wherein the body fluid specimen may be applied from the specimen application side (for example, by dripping and/or coating the specimen) to the test field. In particular, the specimen application side may be specifically arranged at a position opposite to the detection side, for example, on the side opposite to the detection side direction. Therefore, the body fluid sample can be applied to the test field from the sample application side, such as by dripping and/or coating the sample onto the sample application side, for example, to the back of the test field.

In one or more of the disclosed embodiments, the method can be fully or partially implemented by a computer. Therefore, in another aspect, a computer program containing instructions is proposed. When the program is executed by a mobile device with a camera (specifically by the processor of the mobile device), the instructions cause the mobile device to execute the text described herein. The method described, more specifically, is at least steps e) and f) of the method, and optionally steps b) and/or d). In addition, steps a) and c) of the method can also be implemented at least partially by a computer, or at least supported by a computer.

The computer program can be specifically designed as an application, for example as an App. For example, the App can be downloaded from the download server to the mobile device.

As commonly used herein, "computer" may refer to a device having at least one processor and optional other components, such as one or more interfaces, one or more data storage devices, one or more user interfaces, and so on. The term "processor" as used herein is a broad term and should be given its ordinary and customary meanings to those with ordinary knowledge in the technical field, and should not be limited to special or customized meanings. The term may specifically refer to any logic circuit configured to perform the basic operations of a computer or system, and/or generally, refer to, but not limited to, a device configured to perform calculations or logic operations. In particular, the processor can be configured to process the basic instructions that drive the computer or system. For example, the processor may include at least one arithmetic logic unit (ALU), at least one floating-point unit (FPU) (such as an arithmetic co-processor or digital co-processor), and a plurality of Recorder (specifically, a recorder configured to provide operands to the ALU and store operation results), and memory (such as L1 and L2 cache memory). In particular, the processor may be a multi-core processor. Specifically, the processor may be or may include a central processing unit (CPU). Additionally or alternatively, the processor may be or may include a microprocessor. Therefore, specifically, the components of the processor may be included in a single integrated circuitry (IC) chip. Additionally or alternatively, the processor may be or include one or more application-specific integrated circuits (ASIC) and/or one or more field-programmable gate arrays (field-programmable gate arrays, FPGA) and so on.

The computer program may further include instructions. When the program is executed by a mobile device, the instructions further prompt the user to perform one or both of steps a) and c), or confirm that steps a) and c) have been performed One or two.

In yet another aspect, a computer-readable storage medium is disclosed, specifically a non-transitory storage medium, which contains instructions. When the instructions are executed by a mobile device with a camera, it is specifically processed by the mobile device. When the device is executed, the mobile device is caused to execute the method of the present invention, such as any one of the embodiments disclosed above and/or any one of the embodiments disclosed in further detail below. Specifically, at least steps e) and f) of the method can be executed, wherein one or more of steps a), b), c) and d) can also be implemented at least partially by a computer or at least supported by a computer . Therefore, the computer-readable storage medium may further include instructions. When executed by a mobile device, the instructions further prompt the user to perform one or more of steps a), b), c), and d), or confirm One or more of steps a), b), c), and d) have been performed.

As used herein, the terms "computer-readable data carrier" and "computer-readable storage medium" may specifically refer to non-transitory data storage means, such as A hardware storage medium that stores computer executable instructions. The computer-readable data carrier or storage medium may specifically be or may include a storage medium such as random access memory (RAM) and/or read-only memory (ROM).

The computer program can also be embodied as a computer program product. As used in this article, a computer program product may refer to a program that is a tradable product. The product can usually exist in any format (such as a paper format), or on a computer-readable data carrier and/or a computer-readable storage medium. Specifically, computer program products can be distributed on data networks.

In yet another aspect, a mobile device for performing analysis and measurement is disclosed. For the definition and options of mobile devices, you can refer to the descriptions of the methods given above or further outlined below. The mobile device includes at least one camera, at least one display screen, and at least one position sensor, and may include one or more processors. The mobile device is configured to perform at least steps e) and f), and optionally steps b) and/or d) of the method of performing analysis and measurement of the present invention (such as any of the embodiments), such as Any one of the embodiments disclosed above and/or any one of the embodiments described in further detail below. Therefore, the processor of the mobile device can be configured by software to execute and/or control the execution of the method, and perform at least one of steps e) and f) of the method of analysis and measurement, wherein steps a), b), and c) And/or d) can be controlled and/or supported at least in part by the processor.

As outlined above, the mobile device may include at least one processor programmed to control at least one of steps e) and f) of the method of performing analysis and measurement, and optionally step b) and/or d). For definitions and options related to processor design, you can refer to the description given above.

In yet another aspect, a kit for performing analysis and measurement is disclosed. The set includes: -At least one mobile device as described above in this article or as described in further detail below; and -At least one optical test strip, which has at least one test field.

As used herein, the term "kit" is a broad term and should be given ordinary and customary meanings to those with ordinary knowledge in the technical field, and should not be limited to special or customized meanings. The term may specifically refer to a combination of multiple components, but is not limited to it. Each component can function and can operate independently of each other, and the components of the set can interact to perform a common function.

The invention in any of the aspects described herein can provide a number of advantages over such known methods and devices. Therefore, specifically, the present invention can solve the above-mentioned technical challenges. As outlined above, smart phone-based methods usually need to capture at least two images, where at least one image is taken before the specimen is administered and at least one image is taken afterwards, and the at least one image taken thereafter This is called the "wet" image or final image.

The present invention may allow improvement of the measurement safety of analytical measurements. Therefore, when performing analytical measurements, the measurement safety can be improved by monitoring the reaction kinetics. In particular, using the front camera of a mobile device (such as a smart phone) can accurately determine the time to apply the specimen on the test field of the optical test strip. The application time may specifically be or may include the beginning of a reaction, such as a chemical reaction, for example a color change reaction of a test field, and may therefore be related to the measurement performance. In particular, the measurement performance can be improved by accurately determining the application time.

In addition, the present invention can improve the measurement performance by monitoring the reaction kinetics. Specifically, the present invention can provide protection measures against too long and/or too short measurement times by monitoring and/or detecting changes caused by wetting.

Specifically, it is possible to improve the measurement performance by allowing the same or at least similar positioning of the test strip during the period during which the first image or blank image is captured and during the period during which at least one second image or final image is obtained after application of the specimen. accuracy. In particular, the accuracy of measurement can be improved by allowing mobile devices (such as smart phones) to have the same or at least similar positions when capturing the first and second images, for example, by placing the smart phone in a fixed location. Surface, for example on a table. Therefore, specifically when using the front camera of a mobile device (such as the front camera of a smart phone), the mobile device can act as a fixed point when the user locates the optical test strip, so that when capturing an image, it can be at the same or at least Similar positioning. In particular, the present invention can greatly improve the accuracy of measurement by allowing at least one location sensor of the mobile device to check and/or verify the location and/or location of the smartphone.

Generally, the present invention can greatly improve the measurement performance of analytical measurements. Therefore, the measurement performance of the test strip based on the optical analysis of the smartphone can usually be strongly dependent on the conditions of the image taken before and after the application of the specimen. Ideally, the conditions of both images are the same. For positioning, at least one position sensor and/or image recognition technology of the mobile device can be used to determine the conditions so as to improve the measurement performance.

The following summary illustrates and does not exclude more possible embodiments, the following embodiments can be envisaged:

Embodiment 1: A method for performing analysis and measurement based on the color formation reaction in an optical test strip by using a mobile device with a camera, at least one display screen and a position sensor, the method comprising: a) Provide dry optical test strips with test field; b) by using the camera to capture at least one first image of at least a part of the test field of the dry optical test strip where no specimen is applied; c) Apply the body fluid sample to the test field of the optical test strip; d) by using the camera to capture at least one second image of at least a part of the test field of the optical test strip to which the specimen is applied; e) Determine at least one piece of admissibility information. In the case where the location of the mobile device is substantially the same as the location where the first image and the second image are captured, the indication of the admissibility information is admissible, where , To determine the admissibility information based on one or both of the position sensor data and the local position data; and f) If the admissibility information indication is admissible, the first image and the second image of the test field using the optical test strip are used to determine the analytical measurement result value.

Embodiment 2: The method as described in the previous embodiment, wherein the analyte is glucose.

Embodiment 3: The method according to any one of the preceding embodiments, wherein the body fluid is blood.

Embodiment 4: The method as described in the previous embodiment, wherein the method further comprises g) If the admissibility information instruction is not admissible, perform one or both of the following: -Display an error message on the display screen of the mobile device; and -Stop the method of performing analysis and measurement.

Embodiment 5: The method according to any one of the preceding embodiments, wherein step e) of the method includes retrieving at least one first item of position information and at least one second item from the position sensor of the mobile device Location information, and compare the second location information with the first location information, where the first location information includes information about the location of the mobile device when the first image was captured in step b) ( For example, position sensor data), where the second item of position information includes information about the position of the mobile device when the second image is captured in step d) (for example, position sensor data).

Embodiment 6: The method according to any one of the preceding embodiments, wherein step e) of the method includes retrieving at least one first image and second image captured by the camera using the mobile device One piece of position information and at least one piece of second piece of position information, and comparing the second piece of position information with the first piece of position information, where the first piece of position information includes capturing the first image in step b) The local location data of the mobile device at the time, wherein the second item of location information includes the local location data of the mobile device when the second image was captured in step d).

Embodiment 7: The method according to any one of the two preceding embodiments, wherein, in the case that the second item of position information is at least the same as the first item of position information within a predetermined allowable range, Adoptability information instruction is admissible, otherwise the admissibility information instruction is unacceptable.

Embodiment 8: The method according to any one of the preceding embodiments, wherein the local location data includes information about at least one of the following: the relative position between the camera and at least one environmental feature in the camera's field of view; The relative position between the camera and at least one environmental feature in the camera's field of view; the relative position between the camera and the test field in the coordinate system defined by at least one environmental feature in the camera's field of view; the camera and the camera's field of view The relative orientation between at least one environmental feature of the camera; the relative orientation between the test field and at least one environmental feature in the camera’s field of view; in the coordinate system defined by at least one environmental feature in the camera’s field of view, the camera and the test The relative orientation between the fields.

Embodiment 9: The method according to any one of the preceding embodiments, wherein the method may further include the following step: before performing step b) of capturing the first image, waiting for the mobile device to be stationary.

Embodiment 10: The method according to any one of the preceding embodiments, wherein, between performing steps c) and d), a minimum waiting time may pass.

Embodiment 11: The method as described in the previous embodiment, wherein the minimum waiting time is at least 5 seconds.

Embodiment 12: The method according to any one of the preceding embodiments, wherein the camera is a front camera of the mobile device, wherein the front camera of the mobile device and the at least one display screen are both located in the The same side of the mobile device.

Embodiment 13: The method according to any one of the preceding embodiments, wherein in steps b) and d), the mobile device is positioned at a fixed position by one or both of the following: -Use a stand for the mobile device; and -Place the mobile device on a fixed surface.

Embodiment 14: The method as described in the previous embodiment, wherein the fixed surface is a surface selected from the group consisting of: horizontal surfaces, such as table tops, seating surfaces, floors, and shelves; inclined or A sloped surface; a flat surface; an irregular surface.

Embodiment 15: The method according to any one of the preceding embodiments, wherein when at least one first image is captured in step b), the test of the optical test strip is illuminated by using the display screen of the mobile device field.

Embodiment 16: The method according to any one of the preceding embodiments, wherein when at least one second image is captured in step d), the test field of the optical test strip is illuminated by using the display screen of the mobile device .

Embodiment 17: The method according to any one of the two preceding embodiments, wherein, in order to illuminate the test field, at least one area of the display screen of the mobile device is illuminated.

Embodiment 18: The method according to any one of the preceding embodiments, wherein the method further comprises: h) Provide instructions on where to position the optical test strip to capture the first image and the second image by using the mobile device.

Embodiment 19: The method as described in the previous embodiment, wherein the indication of where the optical test strip used to capture the first image is located can be aligned with the position of the optical test strip used to capture the second image Where the instructions are different.

Embodiment 20: The method according to any one of the two preceding embodiments, wherein the indication is provided by using a display screen of a mobile device.

Embodiment 21: The method as described in the previous embodiment, wherein the indication of where the optical test strip is positioned in step h) is included under visual guidance, and the real-time image of the camera is superimposed on the display screen of the mobile device superior.

Embodiment 22: The method as described in the previous embodiment, wherein the visual guidance is selected from the group consisting of: the outline of the target test strip; the pointer indicating the orientation direction of the test strip; at least one word or phrase Indicates the positioning of the test strip.

Embodiment 23: The method according to any one of the preceding embodiments, wherein step d) includes capturing a plurality of second images.

Embodiment 24: The method as described in the previous embodiment, wherein the method includes monitoring the reaction kinetics by using a plurality of second images.

Embodiment 25: The method as described in the previous embodiment, wherein the method comprises using at least one optical test strip, wherein the optical test strip contains at least one reagent element, and wherein the reagent element is configured to be used in the analyte If present, at least one optically detectable detection reaction is performed.

Embodiment 26: The method according to the preceding embodiment, wherein the method includes determining a time course of at least one optical measurement variable, wherein the time course of the optical measurement variable includes a first time period, which is included in the optical measurement variable A sudden change caused by wetting, where the time course of the optically measured variable contains a second time period, which may be after the first time period, where the second time period contains the reaction kinetics used to determine the analyte concentration.

Embodiment 27: The method according to any one of the preceding embodiments, wherein the test field of the optical test strip is arranged on the detection side of the optical test strip, wherein the optical test strip further comprises a specimen application side, wherein the specimen The application side is arranged at a position opposite to the detection side.

Embodiment 28: A computer program containing instructions. When the program is executed by a mobile device with a camera, specifically by the processor of the mobile device, the instructions cause the mobile device to execute any of the preceding embodiments. A method as described, more specifically at least steps e) and f), and optionally steps b) and/or d) of the method described in any one of the preceding embodiments.

Embodiment 29: The computer program as described in the previous embodiment, wherein the computer program further includes instructions. When the program is executed by a mobile device, the instructions further prompt the user to perform steps a) and c) One or two, or confirm that one or both of steps a) and c) have been performed.

Embodiment 30: A computer-readable storage medium containing instructions, specifically a non-transitory storage medium, when the instructions are executed by a mobile device with a camera, specifically by the processor of the mobile device, The mobile device executes the method described in any of the foregoing method embodiments, more specifically at least steps e) and f), and optionally step b) of the method described in any of the foregoing method embodiments And d).

Embodiment 31: The computer-readable storage medium as described in the previous embodiment, wherein the storage medium further includes instructions, and when the instructions are executed by a mobile device, the user is further prompted to perform steps a) and c ) One or both, or confirm that one or both of steps a) and c) have been performed.

Embodiment 32: A mobile device for performing analysis and measurement, the mobile device having at least one camera, at least one display screen, and a position sensor, the mobile device is configured to perform the implementation of the aforementioned method involving performing analysis and measurement At least steps e) and f) and optionally steps b) and/or d) of the method for performing analysis and measurement described in any one of the examples.

Embodiment 33: The mobile device as described in the previous embodiment, wherein the mobile device includes at least one processor programmed to control the execution of any of the preceding embodiments involving methods for performing analysis and measurement At least one of steps e) and f) and optionally steps b) and/or d) of the method for performing analysis and measurement described in the item.

Embodiment 34: A kit for performing analysis and measurement, the kit comprising: -At least one mobile device as described in any of the foregoing embodiments involving mobile devices; and -At least one optical test strip has at least one test field. 【Schematic brief description】

Further optional features and embodiments will be disclosed in the detailed information of the subsequent embodiments, preferably in combination with additional requirements. Among them, individual optional features can be implemented individually or in any feasible combination, as those skilled in the art will implement. The scope of the present invention is not limited to the preferred embodiment. The embodiment uses diagrams to depict graphically. Wherein, those with the same reference numbers in these drawings are used to refer to elements with the same or similar functions.

In these schemes: Figure 1 shows an embodiment of a set and a mobile device for performing analysis and measurement in a perspective view; Figure 2 shows an embodiment of a mobile device for performing analysis and measurement in a front view; Figures 3 to 5 show flowcharts of different embodiments of methods for performing analysis and measurement; Figure 6 exemplarily shows a diagram of the measured reaction kinetics; and Figure 7 shows the comparative blood glucose measurement.

In FIG. 1, an exemplary embodiment of the kit 110 for performing analysis and measurement is shown in a perspective view. The set 110 includes a mobile device 112, such as a smart phone, and further includes at least one optical test strip 114. In the setup shown, the optical test strip 114 is placed in the field of view 116 of the camera 118 of the mobile device 112.

In addition to the at least one camera 118, the mobile device 112 also includes at least one display screen 120, where the display screen 120 can be configured to display real-time images 122 captured by the camera 118 and/or to display information to the user. The mobile device 112 further includes at least one position sensor 124 of the mobile device 112 (such as a position sensor 124 configured to detect one or two positions (such as positioning)) and a position (such as positioning) of the mobile device 112 Variety.

The optical test strip 114 may include at least one substrate 126, such as a bendable, strip-shaped substrate. The optical test strip 114 further includes at least one test field 128 applied to the substrate. The test field 128 includes at least one test chemical for performing a detection reaction with at least one analyte contained in the specimen 130, specifically, by body fluid Sample 130. The specimen may be directly or indirectly applied to the test field 128, such as by applying a drop of body fluid to the test field 128 and/or as exemplarily shown in FIG. Additive 132 is introduced to test field 128.

For example, the display screen 120 of the mobile device 112, as shown in FIG. 2, may include a first area 134, which may be illuminated in order to illuminate the test field 128 of the optical test strip 114. Additionally or alternatively, the mobile device 112 may include at least one illumination source 136, such as an LED, for illuminating the test field 128. In addition, the display screen 120 may include a second area 138 for displaying information to the user.

For example, by appropriately programming the processor 140 of the mobile device 112, the mobile device 112 is configured to perform at least steps e) and f) of the analytical measurement method. The method is described with reference to the exemplary embodiments shown in the flowcharts shown in FIGS. 3, 4, and 5.

By using the mobile device 112 with the camera 118, at least one display screen 120 and the position sensor 124, the method of performing analysis and measurement based on the color formation reaction in the optical test strip 114 includes the following steps, which can be specifically given Execute in the specified order. However, a different order is also possible. It is possible to execute two or more of the method steps simultaneously in a fully or partially synchronized manner. Further, one, more than one, or even all of the method steps may be executed at once or repeatedly. The method may include other method steps not listed. The method steps of this method are as follows: a) (indicated by reference numeral 142) provide a dry optical test strip 114 with a test field 128; b) (indicated by reference numeral 144) by using the camera 118 to capture at least one first image of at least a part of the test field 128 of the dry optical test strip 114 where the specimen 130 is not applied; c) (indicated by reference numeral 146) applying the body fluid sample 130 to the test field 128 of the optical test strip 114; d) (indicated by reference numeral 148) by using the camera 118 to capture at least one second image of at least a part of the test field 128 of the optical test strip 114 to which the specimen 130 is applied; e) (indicated by the reference numeral 150) determine at least one piece of admissibility information, where the item can be used if the location of the mobile device 112 is substantially the same as the location where the first image and the second image are captured. The admissibility information instruction is admissible, wherein the admissibility information is determined based on one or both of the position sensor data and the local location data; and f) (indicated by the reference numeral 152) If the admissibility information is indicated as admissible, the analysis measurement is determined by using the first image and the second image of the test field 128 of the optical test strip 114 The result value.

In addition, as shown in FIG. 4, the method may include a branch point 154. The branch point 154 may indicate a conditional query, such as determining between the first branch 156 and the second branch 158. For example, a conditional query can use the admissibility information. The admissibility information may include Boolean information, such as "admissible" ("y") or "unacceptable" ("n"). For example, the first branch 156 indicates that the admissibility of the analysis measurement result value is determined from the first image and the second image captured by the camera 118 of the mobile device 112. Therefore, the first branch 156 leads to step f), in which the analysis measurement result value is determined by using the first image and the second image of the test field 128 of the optical test strip 114.

If the admissibility information indicates that it is unacceptable, the second branch 158 can indicate that it is unacceptable, and thus leads to step g (indicated by the reference numeral 160) to perform one or both of the following: On the mobile device 112 An error message is displayed on the display screen 120; and the method of performing analysis and measurement is aborted.

As shown in Fig. 5, for example, before determining the analytical measurement result value in step f) 152, step e) 150 can be performed in parallel with other method steps (such as steps b) 144, c) 146 and d) 148. In addition, the method may include other steps, such as instructing the user to locate the mobile device 112 in a fixed position (indicated by the reference numeral 162), for example, by instructing the mobile phone and/or smart phone to be placed on a fixed surface, such as in On the table. Specifically, for example, the execution of step e) can be started from a mobile device (such as a smart phone) and placed on any flat support, such as on a table. Therefore, the position sensor 124 of the mobile device 112 (such as a smartphone sensor) may start to monitor the movement of the mobile device (such as a smartphone). In addition, the method may include a step of requesting analysis and measurement (indicated by reference numeral 164), such as blood glucose measurement, and a step of displaying the measurement result (indicated by reference numeral 166). For example, the displayed measurement result may be a range indicator, indicating that it has detected a range within the analysis measurement. Additionally or alternatively, the displayed measurement result may be an analytical measurement result value. In particular, for example, the measurement result can be displayed on the display screen 120 of the mobile device 112. Although not shown in the figure, other steps are possible, such as informing the user that his phone must be stationary before the measurement sequence starts.

In Figure 6, an example graph of the reaction kinetics is shown. For this experiment, when the specimen is applied to the test field, the mobile device 112 is kept in a fixed position, and the test strip 114 is kept in the field of view of the front camera in a freehand manner. The x-axis in Figure 6 represents consecutive frames (measurement data points); the y-axis shows the counts measured in the red band. In the case of automatically triggering image capture, the number of measurement data points acquired during the reaction may depend on the processing of the user, such as the processing of the optical test strip 114 and/or the mobile device 112 by the user. For example, the automatically triggered image capture may be or may include the number of N images captured per second, where 1 ≤ N ≤ 15, specifically 3 ≤ N ≤ 12, and more specifically 5 ≤ N ≤ 10.

Since the test strip is positioned in the camera's field of view with bare hands, although there is some interference in the signal, the strength drop caused by wetting can be clearly seen from the beginning. In particular, in the graph shown in Figure 6, the change caused by wetting (for example, wetting drop 167) can be or can include more than 25% of the counts measured in the red band as shown on the y-axis Variety. In particular, for example, in Figure 6, in the first period 169 (for example, from the 10th frame to the 16th frame) we can see the change caused by wetting (such as the wetting drop 167), where The reaction kinetics for determining the concentration of the analyte 171 is visible in the second time period 172 (for example, from frame 16 to frame 30). Between frame 0 and frame 10, the count change measured in the red band may be less than 25%, specifically less than 15%. In particular, monitoring changes caused by wetting based on a plurality of second images can be used as a protective measure to rule out that the reaction time between the specimen and the reagent system is too short or too long. In addition, monitoring the changes caused by wetting can also be used to determine the starting point of a chemical reaction, thereby measuring the reaction time. The reaction time can then be considered in determining the analyte concentration.

In Figure 7, the measurement results are shown, which demonstrate the effect of controlling the local position to capture the blank image and the final image. For these experiments, optical test strip 114 and specimen 130 were used to perform blood glucose measurement. Two different settings are used: In the first setting, indicated by the reference number 168, the blank image or the first image, and the final image or the second image, are all shot at the same local position. Specifically, in the first setting 168, the camera 118 is positioned at the same position of the first image and the second image, and the optical test strip 114 is positioned at the same position of the first image and the second image. In the second setting denoted by the reference numeral 170, the blank image or the first image is taken at the common first local position, and the final image or the second image is taken at the common second local position , Wherein the second local position is different from the first local position. Specifically, in the second setting 170, the position of the camera 118 is changed between shooting the first image and the second image, and the position of the optical test strip 114 is also changed between shooting the first image and the second image. In each setting, 10 measurements were performed, where a fresh optical test strip 114 was used for the blank image (no specimen applied), and for the final image, the optical test strip 114 was used 3 days after the application of the specimen. Demonstration (The test field of this test strip has constant optical characteristics, which is different from a fresh optical test strip).

On the horizontal axis, Figure 7 shows two different settings of 168 and 170. On the vertical axis, the determined analytical measurement results are shown. In this case, the blood glucose concentration c is expressed in mg/dl. The result is displayed as a box plot with two settings of 168 and 170. It can be seen that there is a significant difference between the correct or controlled setting 168 and the uncontrolled setting 170. This difference is believed to be mainly due to the difference in lighting conditions between the first local position and the second local position. The difference clearly shows the benefits of the present invention, because shooting the first image and the second image at similar local locations can improve measurement performance, for example, in terms of repeatability and/or accuracy.

110: set 112: mobile device 114: optical test strip 116: camera field of view 118: Camera 120: display screen 122: Real-time image taken by the camera 124: position sensor 126: Matrix 128: test field 130: Specimen 132: Communication Assistant 134: The first area 136: Irradiation Source 138: The second area 140: processor 142: Step a) 144: Step b) 146: Step c) 148: Step d) 150: Step e) 152: Step f) 154: branch point 156: The first branch 158: The second branch 160: Step g) 162: Instruct the user to locate the mobile device in a fixed location 164: Request for analysis and measurement 166: display analysis measurement result value 167: Wetting Drop 168: First setting: the blank image and the final image are shot at the same local position 169: The first period 170: The second setting: the blank image and the final image are shot at different local positions 171: Reaction kinetics used to determine analyte concentration 172: second period

110: set

112: mobile device

114: optical test strip

116: camera field of view

118: Camera

120: display screen

122: Real-time image taken by the camera

124: position sensor

126: Matrix

128: test field

130: Specimen

132: Communication Assistant

140: processor

Claims (15)

A method for performing analysis and measurement by using a mobile device (112) with a camera (118), at least one display screen (120) and a position sensor (124) based on the color formation reaction in the optical test strip (114), The method includes: a) Provide a dry optical test strip (114) with a test field (128); b) by using the camera (118) to capture at least one first image of at least a part of the test field (128) of the dry optical test strip (114) without the specimen (130) applied; c) Apply the body fluid sample (130) to the test field (128) of the optical test strip (114); d) by using the camera (118) to capture at least one second image of at least a part of the test field (128) of the optical test strip (114) to which the specimen (130) is applied; e) Determine at least one piece of admissibility information. In the case where the location of the mobile device (112) is substantially the same as the location where the first image and the second image are captured, the admissibility information is indicated as acceptable Adopt, wherein the admissibility information is determined based on one or both of the position sensor data and the local position data, wherein the local position data is or includes spatial information, and the spatial information refers to at least one environment The location of the feature in the camera's field of view; and f) If the admissibility information indication is admissible, the first image and the second image of the test field (128) of the optical test strip (114) are used to determine the analytical measurement result value. The method described in the previous claim, wherein the method further comprises g) If the admissibility information instruction is not admissible, perform one or both of the following: Display an error message on the display screen (120) of the mobile device (112); and Discontinue the method of performing analysis and measurement. The method according to any one of the preceding claims, wherein step e) of the method includes retrieving at least one first item of position information and at least one first item of position information from the position sensor (124) of the mobile device (112) Two items of location information, and compare the second item of location information with the first item of location information, where the first item of location information includes information about the mobile device (112) when the first image was captured in step b) Wherein, the second item of location information includes information about the location of the mobile device (112) when the second image was captured in step d). The method described in the previous claim, wherein, if the second location information is at least the same as the first location information within a predetermined allowable range, the admissibility information instruction is admissible, Otherwise, the admissibility information instruction is unacceptable. The method according to any one of the preceding claims, wherein the camera (118) is a front camera of the mobile device (112), wherein the front camera of the mobile device (112) and the at least one display The screens (120) are all located on the front of the mobile device (112). The method according to any one of the preceding claims, wherein in steps b) and d), the mobile device (112) is positioned at a fixed position by one or both of the following: Use a stand for the mobile device (112); and Place the mobile device (112) on a fixed surface. The method according to the preceding claim, wherein the fixed surface is a surface selected from the group consisting of: horizontal surfaces, such as table tops, seating surfaces, floors, and shelves; inclined or sloped surfaces ; Flat surface; Irregular surface. The method according to any one of the preceding claims, wherein, when the at least one first image is captured in step b), the display screen (120) of the mobile device (112) is used to illuminate the optical The test field (128) of the test strip (114), wherein when the at least one second image is captured in step d), the optical test is illuminated by using the display screen (120) of the mobile device (112) The test field (128) of Article (114). The method according to any one of the preceding claims, wherein the method further comprises: h) Provide instructions on where to position the optical test strip (114) to capture the first image and/or the second image by using the mobile device (112). The method according to the preceding claim, wherein the indication is provided by using the display screen (120) of the mobile device (112), wherein in step h) the relevant optical test strip (114) The indication of where to locate includes superimposing the real-time image of the camera (118) on the display screen (120) of the mobile device (112) under visual guidance. The method according to any one of the preceding claims, wherein step d) includes capturing a plurality of second images, and wherein the method includes monitoring the reaction kinetics by using the plurality of second images. A computer program containing instructions. When the program is executed by a mobile device (112) with a camera (118), the instructions cause the mobile device (112) to perform at least one of the methods described in any one of the preceding claims. Steps e) and f) and optionally steps b) and d). A computer-readable storage medium containing instructions, specifically a non-transitory storage medium. These instructions, when executed by a mobile device (112) with a camera (118), cause the mobile device (112) to execute as in the aforementioned request At least steps e) and f) and optionally steps b) and/or d) of any of the methods described. A mobile device (112) for performing analysis and measurement. The mobile device (112) has at least one camera (118), at least one display screen (120) and a position sensor (124). The mobile device (112) has It is configured to perform at least steps e) and f) and optionally steps b) and/or d) of the method for performing analysis and measurement as described in any one of the aforementioned claims related to the method for performing analysis and measurement. A set (110) for performing analysis and measurement, the set (110) includes: At least one mobile device (112) as described in any of the aforementioned claims involving a mobile device (112); and At least one optical test strip (114), which has at least one test field (128).

Images